Clinical Trial to Assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

NCT ID: NCT05226897

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2023-06-26

Brief Summary

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Phase 3 study to assess the Efficacy and Safety of YYC405 in Type 2 Diabetes Patients

Detailed Description

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Phase 3 study to assess the Efficacy and Safety of YYC405-T when added to Metformin and Dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel group
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind

Study Groups

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Test

Take YYC405-T and Metformin≥1000mg, Dapagliflozin 10mg

Group Type EXPERIMENTAL

YYC405-T

Intervention Type DRUG

Subjects take the investigational products once a day for 24 weeks.

Metformin≥1000mg

Intervention Type DRUG

Subjects take the investigational products once a day for 24 weeks.

Dapagliflozin 10mg

Intervention Type DRUG

Subjects take the investigational products once a day for 24 weeks.

Placebo control

Take YYC405-T Placebo and Metformin≥1000mg, Dapagliflozin 10mg

Group Type PLACEBO_COMPARATOR

Metformin≥1000mg

Intervention Type DRUG

Subjects take the investigational products once a day for 24 weeks.

Dapagliflozin 10mg

Intervention Type DRUG

Subjects take the investigational products once a day for 24 weeks.

YYC405-T placebo

Intervention Type DRUG

Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.

Interventions

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YYC405-T

Subjects take the investigational products once a day for 24 weeks.

Intervention Type DRUG

Metformin≥1000mg

Subjects take the investigational products once a day for 24 weeks.

Intervention Type DRUG

Dapagliflozin 10mg

Subjects take the investigational products once a day for 24 weeks.

Intervention Type DRUG

YYC405-T placebo

Microcrystalline cellulose, Subjects take the investigational products once a day for 24 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient who contsent to participate in this tiral by written informed consent form
* A man or woman over 20 years old
* Type 2 Diabetes patients

Exclusion Criteria

* Patients with severe renal impairment, end-stage renal disease or on dialysis
* Type 1 diabetes patients
* Patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yooyoung Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sungrae Kim, MD, Ph.D

Role: STUDY_CHAIR

Bucheon St Mary Hospital

Locations

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The Catholic University of Korea(Bucheon St. Mary's Hospital)

Bucheon-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YYPCT_YYC405_301

Identifier Type: -

Identifier Source: org_study_id

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